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Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT00891995
Recruitment Status : Terminated (Primary outcome evaluation determined lack of treatment group difference)
First Posted : May 1, 2009
Results First Posted : October 27, 2016
Last Update Posted : December 30, 2016
Sponsor:
Information provided by (Responsible Party):
Jaeb Center for Health Research

Study Description
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Brief Summary:
The purpose of this study is to find out if very tight blood glucose control from the onset of Type 1 Diabetes can preserve beta cell function. Study subjects will be randomly assigned to receive either standard diabetes management or intensive diabetes management, which involves several days of closed loop therapy followed by home use of a continuous glucose monitor and insulin pump.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Device: Closed loop Device: Home glucose monitoring Device: Insulin pump Device: Continuous glucose monitor Phase 2 Phase 3

Detailed Description:

The specific aim of this study is to determine if early restoration of metabolic control will improve C-peptide production compared to children receiving routine diabetes management and the secondary aim is to determine if allowing the islet cells to be less metabolically active will have an impact on the underlying autoimmune process.

Following completion of the baseline procedures (Mixed Meal Tolerance Test and blood sample collection), participants are randomized to either the Standard Treatment Group or the Intensive Treatment Group which includes 4-6 days of inpatient closed loop therapy followed by outpatient use of an insulin pump and continuous glucose monitor for diabetes management.

All subjects will be seen 7 times in the first year and 4 times in the second year for follow-up testing. Subjects who are still producing insulin after 2 years may be asked to return every 6 months for an additional 2 years.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes
Study Start Date : September 2010
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intensive Treatment
closed loop therapy (4-6 days), insulin pump (2 years), continuous glucose monitoring (2 years), home glucose monitoring (2 years)
 Device: Closed loop
Closed loop therapy for up to 4 to 6 days
Device: Home glucose monitoring
Standard diabetes management using a home glucose meter.
Device: Insulin pump
Insulin pump use for 2 years
Device: Continuous glucose monitor
Continuous glucose monitor use for 2 years
Active Comparator: Standard Treatment
home glucose monitoring (2 years)
 Device: Home glucose monitoring
Standard diabetes management using a home glucose meter.


Outcome Measures
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Primary Outcome Measures :
  1. C-peptide Average Area Under the Curve (AUC) in Response to a Mixed Meal at 1 Year Following Enrollment. [ Time Frame: At baseline, MMTT data were collected at 0 and 90 min; at 12 months, MMTT data were collected at 0 to 240 min post meal ]
    In the primary analysis of the 12-month Mixed-Meal Tolerance Test (MMTT) results, the geometric mean (95% C.I.) of C-peptide average AUC (=AUC/time) was 0.43 (0.34, 0.52) pmol/ml in the intensive treatment group and 0.52 (0.32, 0.75) pmol/ml in the usual care group (P=0.49).


Secondary Outcome Measures :
  1. Peak C-peptide in Response to a Mixed Meal at 1 Year Following Enrollment [ Time Frame: 0 to 240 min post meal at 1 year MMTT ]
  2. Incidence of the Loss of the 2 Hour Peak C-peptide < 0.2 Pmol/ml on a Semi-annual MMTT [ Time Frame: 0 to 240 min post meal at 1 year MMTT ]
    Outcome measure in the table is the incidence of 2 hour peak C-peptide>=0.2 pmol/ml. Since the formal clinical trial stopped at 12 months due to lack of efficiency (later follow-up were used to collect data for secondary analyses by pooling the two groups), only the outcome at 12 months are reported.

  3. HbA1c [ Time Frame: 1 year ]
  4. Adverse Events (Severe Hypoglycemia) [ Time Frame: 1 year ]
  5. CGM Mean Glucose [ Time Frame: 1 year ]
  6. CGM Measured Glucose Outcomes [ Time Frame: 1 year ]
    Include a series of glucose indices created from CGM measured glucose data, such as % time with glucose values <=70 mg/dl, % time with glucose values within target range of 71-180 mg/dl, % time with glucose values >180 mg/dl, and glucose variability as measured by coefficient of variation. These indices were calculated by giving equal weight to each of the 24 h of the day. At least 24 h of CGM data were required for calculating these indices.

  7. Daily Insulin Dose [ Time Frame: 1 year ]
  8. BMI Percentile [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   6 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 6.0 to <46.0 years
  • Diagnosis of type 1 diabetes with initiation of insulin therapy within past 7 days (day 1 being the first day of insulin therapy)
  • If participant is female with reproductive potential, willing to avoid pregnancy and pregnancy test negative.
  • Willing to accept randomization to either the intensive diabetes management group or the standard care group.
  • Willing to complete the planned 2 years of follow-up.
  • Able to electronically transmit data monthly.
  • Investigator believes that the participant (and parent/guardian for children) understands and agrees to comply with the study protocol and is capable of undertaking all necessary testing.

Exclusion Criteria:

  • Currently pregnant or lactating, or anticipate getting pregnant in the next one year.
  • Currently anemic (hematocrit level will be obtained at the screening visit).
  • Chronic use of systemic steroids or other noninsulin pharmaceuticals that might affect glycemic control or the presence of a disease that is likely to be treated with such medications during the first two years of the study.
  • Complicating medical issues that might interfere with study conduct.
  • Inpatient psychiatric treatment in the past 6 months (if the participant is a minor, for either the participant or the participant's primary care giver).
  • Currently participating in another type 1 diabetes treatment study, including an intervention trial for treatment of diabetic ketoacidosis.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00891995


Locations
United States, California
Stanford University
Stanford, California, United States, 94305
United States, Colorado
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80010
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06519
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Jaeb Center for Health Research
Investigators
Study Director: Roy W Beck, M.D., Ph.D. Jaeb Center for Health Research
Principal Investigator: Jay S. Skyler, M.D., M.A.C.P. University of Miami
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Other Publications:

Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT00891995     History of Changes
Obsolete Identifiers: NCT00505206
Other Study ID Numbers: DirecNet 012
First Posted: May 1, 2009    Key Record Dates
Results First Posted: October 27, 2016
Last Update Posted: December 30, 2016
Last Verified: November 2016

Keywords provided by Jaeb Center for Health Research:
Type 1 Diabetes
Closed Loop Therapy
Continuous Glucose Monitor

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs